FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Lens, Contact (Rigid Gas Permeable), Extended Wear
PMA: P880098
·
Decision Sep 1, 1989
Classifications
1
FEI Numbers
16
Registration Numbers
16
Basic Information
- Device Name
- Lens, Contact (Rigid Gas Permeable), Extended Wear
- Trade Name
- MENICON SF-P RGP (MELAFOCON A) CONTACT LENS
- PMA Number
- P880098
- Device Class
- FDA Class 3
- Product Code
- MWL
- Generic Name
- Lens, contact (rigid gas permeable), extended wear
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- September 1, 1989
- Date Received
- December 16, 1988
- Expedited Review
- N
- Docket Number
- 89M-0388
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MWL | Lens, Contact (Rigid Gas Permeable), Extended Wear | FDA class 3 | Ophthalmic |